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April 3, 2014

FDA Approves Sublingual Pill To Treat Hay Fever Symptoms

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redOrbit Staff & Wire Reports - Your Universe Online

In a move that could replace allergy shots for some men and women, the US Food and Drug Administration (FDA) announced on Wednesday that it had approved the first tablet for the treatment of hay fever symptoms.

The product is known as Oralair, according to USA Today’s Kim Painter, it will only work against certain types of grass pollens and will take multiple months before it starts working – meaning that it will not help people with other types of allergies and will not come in time to provide relief for early symptoms this summer.

Oralair is manufactured by a French pharmaceutical company Stallergenes and is the first under-the-tongue (sublingual) allergen extract to be approved in the US, the FDA said. It contains a cocktail of freeze-dried pollen extracts from five different types of grasses (Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal and Timothy) and can be used to treat allergic rhinitis with or without eye inflammation.

The medication is a once-daily, rapidly-dissolving tablet that is to be started four months prior to the grass pollen season and continued throughout the entire hay fever season, the American federal health agency added. The first dose is to be administered at a healthcare provider’s office, so that medical professionals can monitor patients for a period of 30 minutes to monitor for potential side effects. Subsequent doses can be taken at home.

“While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”

Studies evaluating the safety and effectiveness of Oralair were conducted both in the US and Europe and involved about 2,500 people. Some of those patients received the new allergy tablet, while others were given a placebo.

Patients then reported their symptoms and additional medications required to make it through the grass pollen season. During the course of one season, patients who took Oralair experienced a 16 to 30 percent reduction in symptoms and the need for additional medications compared to those who received placebos, the FDA reported.

Dr. James Li, chairman of the division of allergy and immunology at Mayo Clinic in Rochester, Minnesota, told Painter that the success rate was slightly lower than allergy shots in studies, though the two treatment programs have yet to be directly compared to each other.

“The pills can cause some side effects: In studies, one third of patients developed itchy mouths and some reported throat irritation,” Painter said. She also notes that experts believe the fact that the pill is only effective against one type of allergy is a drawback, as most patients suffering from these types of symptoms are also affected by other types of pollens and environmental allergens such as pet dander and dust mites.

The Associated Press (AP) reports that Oralair has been approved for patients between the ages of 10 and 65. The medication was first approved for use in Europe six years ago, and is currently available in 31 different countries, including Australia, Canada and Russia.